The decision by the Food and Drug Administration paves the way for a speedy regulatory review of the BCMA drug for multiple myeloma
GlaxoSmithKline received a boost for its oncology research when an experimental drug for blood cancer received a ‘breakthrough’ designation from US regulators.
The decision by the Food and Drug Administration paves the way for a speedy regulatory review of the BCMA drug for multiple myeloma.
Although GSK sold its marketed cancer drugs to Novartis in 2015, it continues to invest in early-stage research and has said oncology could become another pillar of its pharmaceuticals business, alongside HIV and respiratory medicine. The actions by the US and European regulators are based on promising Phase I clinical trial results, details of which will be announced on December 11 at the annual meeting of the American Society of Hematology meeting in Atlanta.
GSK planned a rapid programme of clinical trials with the new drug, both alone and in combination with other therapies.